Model Number N/A |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
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Event Description
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Three packages were opened at hospital where it was found that the packaging incorrectly identified the product.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.The reported event has been determined to be a coob.The event reports that the labelling on the outer box did not match the device.This was identified during surgery and resulted in a 0-15 min extension to surgery time.An alternative device was used to complete the surgery.No photographs of the implant (photographs of the label have been provided) have been provided and no product has been returned, however, visual inspection of the photographs provided through another complaint ((b)(4)) confirm a commingle has occurred.(b)(4) has been raised to hold product affected by the issue.Issue evaluation ie-(b)(4) has been raised to further investigate the issue.Health hazard evaluation (determination) (b)(4) was raised which was escalated to (b)(4).A review of the complaint database over the last 3 years has found 4 similar complaints reported with these items.A review of the manufacturing history records confirms no abnormalities or deviations reported.H3 other text : product not returned.
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Event Description
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Three packages were opened at hospital where it was found that the packaging incorrectly identified the product.
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Search Alerts/Recalls
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